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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

The US Food and Drug Administration (FDA) has agreed to modify the dosage regimen for Bristol-Myers Squibb’s cancer treatment Opdivo (nivolumab) for the currently approved indications of renal cell carcinoma, metastatic melanoma and non-small cell lung cancer.

The modification of the “Dosage and Administration” section of the label replaces “the single dose regimen of nivolumab (3 mg/kg intravenously every two weeks) with the new recommended regimen of 240 mg IV every two weeks until disease progression or intolerable toxicity for renal cell carcinoma, metastatic melanoma, and non-small cell lung cancer.”

In addition, FDA said the nivolumab dosing regimen in combination with ipilimumab for melanoma will remain the same (nivolumab 1 mg/kg IV, followed by ipilimumab on the same day, every three weeks for four doses). However, after completion of ipilimumab, the recommended nivolumab dose will be 240 mg every two weeks until disease progression or intolerable toxicity, FDA added. The recommended dose for classical Hodgkin lymphoma remains 3 mg/kg IV, every 2 weeks until disease progression or intolerable toxicity, the agency said.

An FDA spokesman also told Focus: "One of the most compelling arguments to be made regarding flat dosing is the elimination of excess drug waste. Other considerations include convenience to health care providers and reduced concerns regarding accurate dosing in patients with weight fluctuations."

The agency based its approval on population pharmacokinetics analyses and dose/exposure-response analyses demonstrating the comparability of the pharmacokinetics exposure, safety and efficacy of the proposed new dosing regimen with the regimen that was previously approved.

“Based on simulations by the population pharmacokinetics model, FDA determined that the overall exposure at 240 mg every two weeks flat dose is similar (less than 6% difference) to 3 mg/kg every two weeks. These differences in exposure are not likely to have a clinically meaningful effect on safety and efficacy, since dose/exposure response relationships appear to be relatively flat in these three indications,” FDA added in a statement posted on Thursday.

Jaisy Wagner Styles, director of public affairs at Bristol-Myers Squibb, told Focus: "For the indications in non-small cell lung cancer (NSCLC),
renal cell carcinoma (RCC) and unresectable or metastatic melanoma – this flat
dose is intended to standardize dosing across all patients regardless of body
weight and also to provide convenience to healthcare professionals in the
preparation and administration of Opdivo (nivolumab).

"There is a broad range of patient weights across advanced
RCC previously treated with anti-angiogenic therapy, previously treated
metastatic NSCLC, and unresectable or metastatic melanoma as a single agent
patients. Some patients will receive a slightly higher dose, some will
receive a lower dose, and for others the dose will not change," she added.